The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.

A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)

ECOG < or = 2

Willing to agree to follow the pregnancy precautions.

Exclusion Criteria:

Pregnant or nursing women

Systemic treatment for B-cell CLL within 28 days of study start

Central nervous system involvement

History of renal failure requiring dialysis

Prior treatment with lenalidomide

Alemtuzumab therapy within 56 days of initiating lenalidomide treatment

ANC < 1000 / ul

Platelet count < 50,000 / ul

Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)

AST or ALT > 3.0 x upper limit of normal

Serum total bilirubin > 2.0 mg/dl

Neuropathy > or = Grade 2

Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

Richter's transformation (active)

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419250